Health Freedom Ireland (HFI) encourages you to become fully informed about vaccines and the associated illnesses so that you can give informed consent if you choose to vaccinate yourself or your child(ren). This information is for educational purposes only and is not intended as medical advice. HFI is simply bringing this information to you – we neither recommend nor advise against vaccination.

The following tables was compiled from studies listed on clinicalTrials.gov. We excluded any studies that did not have results posted or where the vaccine in question was not given as the intervention (it may have been a pre-requirement for another study for example). Click on the study titles to see the details including what adverse events were tracked in each case and for specifics on the timeframes. It is worth bearing in mind that phase 3 clinical trials for drugs are usually between 1 and 4 years and phase 4 trials are as long or even longer than this. This is the case even for drugs for terminally ill patients. Any medical products for healthy babies should be even longer. One reason is that many conditions will not be possible to diagnose until children are older and the other is that if it causes adverse effects – particularly chronic illnesses – it can have devasting effects for the child for the rest of their lives.

Click on the links to jump to the section for each vaccine:

• Infanrix Hexa (6-in-1) vaccine trials
• Measles Mumps Rubella (MMR) vaccine trials

Infanrix Hexa (6-in-1) vaccine trials

ClinicalTrials.gov trials for Infanrix Hexa

Study Title	Number participants	Timeframe for local/general adverse effects	Timeframe for serious adverse effects
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery	551	30 days	10 months
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals’ Infanrix Hexa™ (DTPa-HBV-IPV/​Hib) Vaccine	224	31 days	7 months
V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)	403	14 days (doesn’t specify local/serious)
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants	1106	12 months post vaccination
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)	1250	2 months after toddler dose
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age	230	30 days after each dose	30 days after third dose
Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine	709	30 days after each vaccination	Study duration
Immunogenicity and Safety of DTPa-HBV-IPV/​Hib Compared to DTPa-IPV/​Hib and HBV Administered Concomitantly	312	30 days after each vaccine	30 days post vaccination
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age	230	31 days	Up to month 5
Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants	585	31 days	From month 0 up to 6 months post-primary vaccination (month 10)
Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine	793	31 days	7 months
Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course	494	31 days	30 days after last vaccination (at 10 months)
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery	601	31 days	From day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A	750	31 days	12 months
Study of a New Formulation of DTPa-HBV-IPV/​Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children	283	31 days	Up to one month after booster dose
A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)’s Infanrix Hexa Vaccine (DTPa-HBV-IPV/​Hib) Versus MCM Vaccine BV’s Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers	500	31 days	Day 1 to month 11
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants	286	31 days	Month 0 – month 10, including the 5 months extended safety follow-up
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio’s DTPa-HBV-IPV/​Hib Vaccine	403	31 days	From month 0 to month 1
3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age	388	31 days	Up to month 3
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals’ GSK2202083A Vaccine Administered as a Booster Dose	391	31 days	From month 0 to month 1
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/​Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately	440	31 days	Month 0 to month 9
Study of GlaxoSmithKline Biologicals’ GSK2202083A Vaccine in Healthy Infants	480	31 days	Month 0 to month 11
Immunogenicity and Safety Study of GSK Biologicals’ GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age	421	31 days	Month 0 to month 3
Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/​Hib	780	31 days	Up to month 21
Immunogenicity and Safety of Two Formulations of GSK Biologicals’ Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants	953	31 days	Day 0 to month 11
This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa	301	31 days	Month 0 to month 1
Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children	185	31 days	Study duration
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old	461	31 days	From month 0 up to month 13
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/​Hib in Healthy Infants	576	31 days	Months 0-11
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/​Hib Vaccine (GSK217744)	721	31 days	Months 0-3
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age	466	31 days	Month 0 to month 4
Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines	1437	31 days	6 months
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule	351	31 days	During both primary and booster vaccination periods
Immunogenicity and Safety of GSK Biologicals’ Infanrix Hexa in Infants	224	31 days	Study duration
Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose	238	31 days after booster	month 0 to month 1
Primary Vaccination Study With GSK Biologicals’ Pneumococcal Vaccine in Healthy Infants in Vietnam	300	31 days after each dose	After the first vaccination up to study end (From month 0 to month 3)
Study to Evaluate GlaxoSmithKline (GSK) Biologicals’ MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants	500	31 days after each vaccine	30 days after last vaccine dose
Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/​Hib Vaccine	121	31 days following primary and booster
https://clinicaltrials.gov/study/NCT01144663?tab=table#outcome-measures	2095	31 days post booster vaccination	From booster vaccination (month 10) up to Extended Safety Follow-Up (ESFU) (month 16)
Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children	300	4 days	Day 0 to month 1
Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)	955	42 days (doesn’t specify local/serious)
Hepatitis B Vaccination in Infants (Infanrix)	300	7 days
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom (MET52)	788	7 days
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules	1885	7 days	Study duration
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants	412	7 days post vaccination	Up to 10 months post-vaccination.
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/​Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine	80	After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall	Month 0 to month 9
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants	1375	Day 0 after dose 1 through up to 6 months after the last dose.
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)	1315	day 1 to day 15	Up to 11 months
Bexsero™and Routine Infant Vaccines: Effect of Coadministration on the Safety of Immunization	4535	Day 13
A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy	302	Days 0-30	Days 0-30
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) (PNEU-PED-EU-1)	1184	Days 1 to day 14 following each vaccination	Day 1 up to approximately study month 20
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™	881	From day 0 after the booster injection to up to 6 months post-booster injection.
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants	3630	from day 8 after each vaccination to next vaccination or to 30 days after the last vaccination.
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals’ 10-valent Pneumococcal Conjugate Vaccine.	1200	From month 1 and up to Month 6 (Extended Safety Follow-Up)
COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine	23802	Months 0 to 22-25	Months 0 to 22-25
Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination	558	No vaccine administered
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants	263	Up to 30 days after each injection	Up to 30 days after each injection
Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.	150		Day 0 up to day 28 post-vaccination
Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule	163		Study duration (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)
Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand	370
To Evaluate Immunogenicity & Safety of GSK Bio’s DTPa-HBV-IPV/​Hib (Mixed Vaccine) and DTPa-IPV/​Hib + HBV Vaccines	150

Measles Mumps Rubella (MMR) vaccine trials

ClinicalTrials.gov trials for MMR vaccines

Notes:

• There was just one completed trial for the MMR-Vax-Pro vaccine given in Ireland.
• The average number of participants in each study was 1,296 – most had less than 500. This is not sufficient to detect problems that might happen to one child in 10,000.
• General adverse events were monitored for approximately 2.5 months on average.
• Serious adverse events were monitored for 7 months on average.
• Phase 3 trials for drugs usually take between 1 and 3 years and phase 4 trials can be even longer.